Stabilization and guide apparatus for access to an implanted access port and related methods

ABSTRACT

An insertion device to assist in accessing an access port that has been subcutaneously implanted in the body of a patient is disclosed. The implanted access port is accessed by a needle of a needle assembly, such as a needle-based infusion set. In one embodiment, the insertion device comprises a body that includes a stabilizing portion and a guide portion. The stabilizing portion stabilizes a position of the implanted access port when the body is placed on the skin of the patient atop the implanted access port. The guide portion guides a needle of the needle assembly along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Nos. 61/949,972, filed Mar. 7, 2014, and titled“Stabilization and Guide Apparatus for Access to an Implanted AccessPort and Related Methods,” and 62/048,679, filed Sep. 10, 2014, andtitled “Guidance Device for Access to an Implanted Access Port,” both ofwhich are incorporated herein by reference in their entireties.

BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed toan insertion device to assist in accessing an access port that has beensubcutaneously implanted in the body of a patient. The implanted accessport is accessed by a needle of a needle assembly, such as aneedle-based infusion set. In one embodiment, the insertion devicecomprises a body that includes a stabilizing portion and a guideportion. The stabilizing portion stabilizes a position of the implantedaccess port when the body is placed on the skin of the patient atop theimplanted access port. The guide portion guides a needle of the needleassembly along a predetermined path such that the needletranscutaneously pierces a septum of the implanted access port.

In another embodiment, the insertion device includes a housing that isplaced on the skin of the patient over the location of the implantedport in a manner that prevents the port from undesirably moving about inthe subcutaneous tissue pocket in which the port is disposed. Once theimplanted port is stabilized in this manner, a needle guide component ofthe device can receive therein a needle of the needle assembly and guidethe needle as it is advanced in a downward direction in such a way as topierce the skin and accurately penetrate the septum of the implantedport until the needle establishes fluid communication with the portreservoir. Fluid infusion and/or aspiration can then occur. The needlecan similarly be retracted from the implanted port by reversing theabove process.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of embodiments of theinvention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description of the present disclosure will be renderedby reference to specific embodiments thereof that are illustrated in theappended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. Example embodiments of the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIGS. 1A-1F are various views of an insertion device and needle assemblyaccording to one embodiment;

FIGS. 2A-2C show various views of the insertion device of FIGS. 1A-1F;

FIGS. 3A-3B show various views of the needle assembly of FIGS. 1A-1F;

FIGS. 4A-4C show various stages of use of the insertion device of FIGS.1A-1F;

FIG. 5 is a cross-sectional side view of an insertion device accordingto one embodiment;

FIG. 6 is a cross-sectional side view of an insertion device accordingto one embodiment;

FIG. 7 is a cross-sectional side view of an insertion device accordingto one embodiment;

FIG. 8 is a cross-sectional side view of an insertion device accordingto one embodiment;

FIG. 9 is a cross-sectional side view of an insertion device accordingto one embodiment;

FIG. 10 is a cross-sectional side view of an insertion device accordingto one embodiment;

FIG. 11 is a cross-sectional side view of a portion of an insertiondevice according to one embodiment;

FIG. 12 is a simplified cross-sectional side view of an insertion deviceaccording to one embodiment;

FIGS. 13A-13E are various views of an insertion device according to oneembodiment; and

FIG. 14 is a perspective view of an insertion device according to oneembodiment.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the present invention, and are neither limiting nornecessarily drawn to scale.

For clarity it is to be understood that the word “proximal” refers to adirection relatively closer to a clinician using the device to bedescribed herein, while the word “distal” refers to a directionrelatively further from the clinician. For example, the end of acatheter placed within the body of a patient is considered a distal endof the catheter, while the catheter end remaining outside the body is aproximal end of the catheter. Also, the words “including,” “has,” and“having,” as used herein, including the claims, shall have the samemeaning as the word “comprising.”

Embodiments of the present invention are generally directed to aninsertion device to assist in providing needle access to an access portthat has been subcutaneously implanted in the body of a patient. Theneedle is included as part of a needle assembly, such as a port accessneedle, and provides a fluid conduit through which medicaments or otherfluids can be provided to or removed from the implanted access port.

The insertion device disclosed herein includes a stabilizing portionthat is placed on the skin over the subcutaneously implanted access portto prevent undesired movement of the access port within its subcutaneouspocket. The insertion device further includes a guidance portion that isemployed to temporarily secure the needle assembly to the insertiondevice and to guide insertion of a distal portion of the needle into theseptum of the implanted access port so as to provide fluid access to thereservoir of the access port. Once the needle of the needle assembly issuitably inserted into the access port, the insertion device can beremoved from the needle assembly and the needle assembly can be dressedand used.

Reference is first made to FIGS. 1A-1F, which depict various views of aport needle insertion device (“insertion device”), generally designatedat 10, for assisting in providing needle access to an access port thathas been subcutaneously implanted into the body of a patient, accordingto one embodiment. As shown, the insertion device 10 includes astabilization and guide body (“body”) 20 extending between a proximalend 20A and a distal end 20B. A tower-like proximal portion 22 extendsabove the generally cylindrical lower portion of the insertion device10, as seen in FIGS. 1A and 1B.

The lower portion of the insertion device 10 defines a generallycylindrical cavity 32, though other cavity shapes are contemplated. Thecavity 32 is sized so as to receive therein a portion of a needleassembly 30 (FIGS. 3A, 3B), such as a port access needle, for instance,as will be described below. The needle assembly 30 is removably attachedto the insertion device. A slot 34 is defined in the body 20 adjacentthe cavity 32 so as to enable separation of the needle assembly 30 fromthe insertion device 10 after use thereof is no longer needed.

The insertion device body 20 defines oppositely-disposed, rounded fingercutouts 36 that open to the distal end 20B of the body and the cavity 32and assist with grasping the skin about the implanted access port whileusing insertion device 10. The shape, size, and position of the fingercutouts can vary. A radially outward extending lip 38 is defined aboutthe perimeter of the distal end 20B of the insertion device body 20 toassist with placement of the insertion device on the skin of the patientduring use. The lip 38 extends between both finger cutouts 36. Thedistal end of the insertion device body 20 including the lip 38, as wellas the cavity 32, cooperate to define a stabilization portion of theinsertion device, according to one embodiment.

In the present embodiment, a lip extension 38A is also defined about thefinger cutout 36 shown in FIG. 1B to help a user grasp the insertiondevice 10 during use.

Reference is made to FIGS. 3A and 3B, which depict various details ofthe needle assembly 30 according to the present embodiment. As shown,the needle assembly 30 includes a hub 62 that defines a cavity 64therein. A hollow needle 66 including an open distal tip 66A (FIG. 4B)is attached to the hub 62 and extends distally from the cavity 64. Afluid inlet 68 is included on the hub 62 and is in fluid communicationwith the needle 66. Tubing is typically connected to the fluid inlet 68.

The needle assembly 30 further includes a base 70 that is slidablydisposed on the needle 66. A hole 72 is defined in the base to enablethe needle 66 to extend therethrough. A pad 74 is attached to a bottomsurface of the base 70. The base 70 is slidable along the needle 66 soas to be positioned adjacent the hub 62 such that a portion of the baseis received into the cavity 64 and the distal tip 66A of the needle 66extends through and beyond the hole 72. As shown in FIGS. 3A and 3B, thebase 70 can also be extended distally from the hub 62. A safetymechanism is included in the base 70 so as to lock the base over thedistal tip 66A of the needle 66 to prevent contact therewith when thebase is distally extended a sufficient amount.

A retainer component, such as a needle hub retainer 40, is included withthe insertion device 10 to retain the needle assembly 30 and to guide aneedle 66 thereof into a septum of the subcutaneously implanted accessport. As shown, the needle hub retainer 40 includes a projection 42 thatextends through a slit 44 longitudinally defined in the proximal portion22 of the body 20. This enables the needle hub retainer 40 to slideproximally and distally along the proximal portion of the body 20.

The above-referenced slit 44 is in communication with a hole 48 definedpartly by two spring arms 46, best seen in FIG. 1B. During initialassembly of the insertion device, the projection 42 of the needle hubretainer 40 is inserted through the hole 48, then slid proximally towardthe proximal end 20A of the body 20. This causes the spring arms 46 toflex outward to enable the projection 42 to pass between the springarms, assisted by the proximally-angled arm surfaces. Once theprojection has passed them, the spring arms 46 return to their positionsshown in FIG. 1B, thus preventing the projection from re-entering thehole 48. In addition to this, other schemes for attachment of the needlehub retainer 40 to the body 20 are contemplated, as are differingdesigns for the needle hub retainer itself, such as in the case ofaccommodating other needle assembly designs.

FIGS. 1E, 1F, 2A, and 2B show that the needle hub retainer 40 furtherincludes two articulating wings 50, with each wing including a tooth 52.FIGS. 1E and 1F show that the teeth 52 and wings 50 are employed to foldabout and capture the hub 62 of the needle assembly 30 (FIGS. 3A, 3B) soas to restrain travel of the hub while the needle assembly is attachedto the insertion device 10. In particular, the teeth 52 are configuredto engage the cavity 64 defined in the hub 62 of the needle assembly 30so as to create a secure engagement between the needle hub and theneedle hub retainer 40 when in the proximal position as shown in FIGS.2C and 4A.

The needle hub retainer 40 is disposed in a longitudinal channel 54defined by the proximal portion 22 of the body 20. Disposal of theprojection 42 in the slit 44 keeps the needle hub retainer within thechannel 54. The channel 54 includes parallel sides in a more proximalregion that taper away from each other in a more distal tapered region56 as the channel approaches the lower portion of the body 20. Theneedle hub retainer can travel distally until the projection 42 contactsthe tops of the spring arms 46. So configured, it is appreciated thatthe needle hub retainer 40 and the channel 54 can guide movement of theneedle assembly 30, as will be described below, and thus serve as aguide portion of the insertion device 10 in the present embodiment.

FIGS. 4A-4C depict the manner in which the needle assembly 30 isdisposed in the insertion device and the nature of needle assemblymovement therewithin. In particular, FIG. 4A shows the needle assembly30 attached within the insertion device 10 such that the needle hub 62is captured by the needle hub retainer 40 in the manner described above,and the base 70 is disposed in the cavity 32 of the body 20. FIGS. 1Cand 2B show that four upper retention surfaces 58A and fourcorresponding lower retention surfaces 58B cooperate to sandwich thebase 70 of the needle assembly and maintain it in place within thecavity 32. Of course, other retention modes could be employed.

FIG. 4B shows that a proximal portion of the slit 44 includes a slitadjustment zone 45. In one embodiment, during manufacture of theinsertion device body 20 detail measurement of the length of the needle66 are taken and the slit 44 can be lengthened as necessary by wideningthe slit adjustment zone to compensate for slight variations in theneedle length, which can change from needle to needle. A punch-out toolor other device can be used to lengthen the slit 44 in the slitadjustment zone 45. Such adjustment enable the distal tip 66A of theneedle to reside (before insertion device use) within the base 70 of theneedle assembly 30 but distal to the safety assembly included in thebase so as to enable the distal tip to emerge therefrom when extendeddistally to engage the septum of the implanted access port. Of course,other modes for extending the slit length can also be devised.

In the position shown in FIG. 4A, the insertion device 10 is ready to beplaced on the patient's skin atop a subcutaneously implanted port inpreparation for inserting the needle 66 of the needle assembly 30 intothe port. In particular, the distal end 20B of the insertion device body20 including the lip 38 is placed on the skin such that the perimeterdefined by the distal end 20B circumscribes the implanted port. Somedownward pressure on the insertion device body 20 may be used such thata portion of the skin-covered implanted port is raised into the cavity32. This stabilizes the position of the implanted access port andprevents it from sliding, rotating, or otherwise undesirably movingduring the needle insertion procedure. Further, placement of theinsertion device 10 over the implanted access port centers the port inthe cavity of 32 of the body 20, thus aligning the septum of the portwith the needle 66 of the needle assembly 30 attached to the insertiondevice, so as to ensure accurate mating of the needle with the port, asdescribed further below. Note that in other embodiments the size andcross-sectional shape of the cavity 32 can vary from the generally roundconfiguration discussed here. For instance, the cross-sectional shapecan be triangular, square, etc., in one embodiment.

Once the position of the implanted access port is stabilized, downward(distal) force can be applied to the needle hub 62, which causes thedistal movement of the needle hub retainer 40, which is securelyattached to the needle hub. Given the disposal of its projection 42within the slit 44, the needle hub retainer 40 is constrained in itsmovement to a predetermined, substantially vertical (distal), path.Because of its attachment to the needle hub retainer 40, the needle hub62 is likewise restricted in its movement in the same predetermined,vertical (distal) path. “Predetermined path,” as used herein, includespassage of the needle along a desired path that leads to a septum of animplanted port or other desired subcutaneous target. The distallydownward movement of the needle hub retainer 40 and needle hub 62 causesthe corresponding distal movement of the distal tip 66A of the needle 66from beyond the hole 72 of the base 70 and past the distal end 20B ofthe insertion device body 20, as shown in FIG. 4B.

Distal advancement of the needle 66 as just described in turn causes thedistal tip 66A of the needle to penetrate the patient skin and piercethe septum of the implanted access port. Such insertion of the needledistal tip 66A is facilitated by the stabilizing and centering functionof the implanted access port by the insertion device 10 as describedabove, desirably easing mating of the needle to the port by theclinician. During the needle insertion procedure, one hand of theclinician can be used to hold the insertion device body 20 (using thefinger cutouts 36 for a thumb and finger, for example) against thepatient skin to stabilize the implanted access port, while the otherhand is used to apply downward pressure to the needle hub 62 to distallyadvance the needle 66 into the port.

FIG. 4B shows that distal advancement of the needle hub 62 (and,correspondingly, the needle 66), as constrained by the needle hubretainer 40, causes the needle hub retainer to slide distally down thechannel 54 and into the outwardly tapered region 56 thereof. This inturn enables the living-hinged wings 50 to spread outwardly, whichcauses the teeth 52 to disengage from the cavity 64 of the needle hub62. This frees the needle hub 62 from physical engagement with theneedle hub retainer.

In light of the above disengagement of the needle hub retainer 40 fromthe needle hub 62, once the needle 66 has been acceptably inserted intothe implanted access port, the insertion device 10 can be removed fromthe needle assembly 30 by lifting the insertion device vertically fromthe patient's skin surface. Compliance of the insertion device body 20enables sufficient deformation for the needle assembly base 70 to freeitself from retention by the lower retention surfaces 58B. As theinsertion device is lifted from the patient's skin and past the insertedneedle assembly 30, the tubing typically attached to the fluid inlet 68of the needle hub 62 can pass through the slot 34 of the insertiondevice body 20, thus enabling full removal of the insertion device fromthe needle assembly. After its removal, the insertion device will appearsubstantially as shown in FIG. 4C.

It is appreciated that the insertion device can be modified so as toaccommodate other types, sizes, and configurations of needle assembliessuch that the stabilization and guide functions of the insertion devicecan be realized for other needle assemblies.

FIG. 14 depicts details of the insertion device 10 including a needlehub retainer according to another embodiment. As shown, the proximalportion 22 of the insertion device body 20 includes attached thereto aneedle hub retainer 140 for releasably retaining the needle hub 62 ofthe needle assembly 30. The needle hub retainer 140 is slidably attachedto the body 20 via two projections 142 that are slidably received intotwo corresponding grooves 144.

The needle hub retainer 140 includes two living-hinged wings 150 thateach include one of two teeth 152 that serve to engage with hub portionssurrounding a cavity defined by the needle hub 62 (a portion of theneedle hub 62 is hidden here for clarity) to maintain attachment of theneedle hub retainer 140 with the needle hub 62. Each wing 150 includes apin that is slidably received within a corresponding one of two channels154, as shown. The channels 154 each include a diverging region 156 thatdiverges outward from a more proximal parallel portion of the channel.Thus, as the needle hub retainer 140—initially retaining the needle hub62—is slide distally down toward the cavity 32, the wings 150 are spreadoutward due to the tracking of the pins 160 within the correspondingdiverging regions 156 of the channels 154. This causes the teeth 152 torelease from engagement with the needle hub 62, which enables the needlehub to separate from the needle hub retainer 140 when separation of theinsertion device 10 from the needle assembly 30 is desired afterinsertion of the needle 66 into the implanted access port. This andother variations of the needle hub retainer are therefore contemplated.

Note that, in one embodiment, the insertion device body 20 can include apair of snap arms that can be used to removably retain tubing of theneedle assembly 30.

FIG. 5 shows a port needle insertion device (“insertion device”) 110according to another embodiment, wherein the insertion device includes around body 120 extending between a proximal end 120A and a distal end120B. The body 120 defines an annular rim 122 that circumscribes aremovable, disk-like barrier 126. The barrier 126 defines a hole 124 toserve as a conduit through which a needle can be advanced. The barrier126 in one embodiment includes foam or other suitable material thatincludes a useful component, such as an antimicrobial agent, ahemostatic agent, or both, for instance. In one embodiment, the barrier126 is a GUARDIVA® Antimicrobial Hemostatic Dressing (“GUARDIVA®dressing”) sold by Bard Access Systems, Salt Lake City, Utah, USA. Sucha GUARDIVA® dressing can also be included with the insertion devicedescribed and shown in connection with the embodiment of FIGS. 1A-4C, inone embodiment, and with the other embodiments described herein.

The insertion device 110 is shown in FIG. 5 placed over a subcutaneouslyimplanted access port 80 under the skin 84 of the patient so as tostabilize the position of the port via downward pressure of the annularrim 122 and to align the port with the hole 124 so that a needle passedthrough and guided by the hole along a predetermined path can intercepta septum 82 of the port, as desired. Being removable from the insertiondevice 110, the barrier 126 can be left interposed between the needleassembly 30 and the patient skin 84 after insertion of the needle 66into the septum 82 of the implanted access port 80. In anotherembodiment, no barrier is included with the insertion device 110.

FIG. 6 shows a port needle insertion device (“insertion device”) 210according to another embodiment, wherein the insertion device includes ahollow cylindrical body 220 extending between a proximal end 220A and adistal end 220B. The insertion device 210 includes a slide portion 224slidably mounted to the body 220, which removably supports the hub 62 ofthe needle assembly 30, similar to the needle assembly discussed inconnection the embodiment of FIGS. 1A-4C. The slide portion 224 isdistally slidable to distally advance the needle into an implantedaccess port stabilized by the distal end of the insertion device body220. A needle cover 230 is shown in FIG. 6 removably attached to thedistal end 220B of the insertion device body 220 and is used to protectthe distal tip of the needle 66, but is removed prior to use of theinsertion device 210.

As mentioned, the distal end of the insertion device body 220 serves asa stabilization portion for stabilizing the implanted access port whenthe insertion device 210 is placed over the implanted port. The slide224 serves as a guide portion for guiding the needle along apredetermined path into the septum of the stabilized, implanted port, asdesired. A longitudinal slot can be included in the insertion devicebody to enable detachment of the insertion device 210 from the needleassembly 30 after insertion of the needle 66 into the implanted accessport.

FIG. 7 shows a port needle insertion device (“insertion device”) 310according to another embodiment, wherein the insertion device includes ahollow cylindrical body 320 extending between proximal and distal ends320A, 320B. The needle assembly 30 is supported within the hollow body320 such that it is slidable to distally advance the needle through ahole 324 defined in a barrier 322, also removably mounted within thehollow body 320. The barrier 322 in the present embodiment includesantimicrobial and hemostatic components, such as a GUARDIVA® dressing,so as to provide antimicrobial/hemostatic effect to the needle 66 whenit passes through the hole 324 in the barrier. The barrier 322 can alsoserve as a needle guide for the needle 66, in one embodiment.

A lower body portion 321 that includes a design similar to that of theinsertion device 110 shown in FIG. 5, can be included on the distal end320B of the body 320 to serve as a stabilization portion for stabilizingthe implanted access port 80 when the insertion device 310 is placedover the implanted port. In addition, the body 320 and the barrier322/hole 324 can serve as a guide portion for guiding the needle along apredetermined path into the septum 82 of the stabilized, implantedaccess port 80, as desired. The barrier 322 can detach from theinsertion device 310 after needle insertion and can remain with theneedle assembly 30 as a dressing, in one embodiment. The lower bodyportion 321 can be made to be removable from the rest of the body 320,in one embodiment.

FIG. 8 shows a port needle insertion device (“insertion device”) 410according to another embodiment, wherein the insertion device 410includes a body 420 extending between proximal and distal ends thereof.The body 420 defines a plurality of articulating, living-hinged arms 422that support the base 70 of the needle assembly 30 at the proximal endof each arm. In the illustrated embodiment, four arms 422 are includedon the body 420. The arms 422 are collapsible so as to enable the needle660 to be distally advanced through a hole 424 in a barrier 426, such asa GUARDIVA® dressing in one embodiment, disposed distal to the arms. Asbefore the barrier 426 can serve as a needle guide, and can be removableto remain with the needle assembly 30 after insertion of the needle 66into the implanted access port 80.

A distal portion of the body 420 is shaped to define a cavity and serveas a stabilization portion for stabilizing the implanted access portwhen the insertion device 410 is placed over the implanted port, asshown. The arms 422 (and the barrier 426 in one embodiment) serve as aguide portion for guiding the needle 66 along a predetermined path intothe septum 82 of the stabilized, implanted port when the arms 422 arecollapsed by user force on the needle hub 62. After needle insertion,the insertion device 410 can be lifted over and removed from the needleassembly 30.

FIG. 9 shows a port needle insertion device (“insertion device”) 510according to another embodiment, wherein the insertion device includes ahollow body 520 extending between a proximal end 520A and an annulardistal end 520B and defining a cavity 522. The needle assembly 30 isremovably disposed within the cavity 522, wherein the needle assemblybase 70 is supported by one or more retention surfaces. A guard 524 isprovided proximally above a portion of the needle hub 62 so as toprevent unintended proximal pulling of the needle hub, which wouldprematurely safety the distal tip of the needle 66 within the base 70. Aportion of the needle hub 62 is left uncovered so as to enable distaluser force to be placed thereon. The needle hub 62 can be pushed by auser to distally advance the distal tip of the needle 66 past the distalend 520B the body 520 and into a subcutaneously implanted access port.

The annular distal end 520B of the insertion device body 520 is shapedto serve as a stabilization portion for stabilizing the implanted accessport when the insertion device 510 is placed over the implanted port.Securement of the base 70 within the cavity 522 of the body 520 toenable the needle 66 to be slid relative to the base enables theinsertion device 510 to serve as a guide portion for guiding the needlealong a predetermined path into the septum of the stabilized, implantedport, as desired. A slot can be provided to enable removal of theinsertion device 510 from the needle assembly 30 after insertion of theneedle 66.

FIG. 10 shows a port needle insertion device (“insertion device”) 610according to another embodiment, wherein the insertion device includes ahollow body 620 extending between proximal and distal ends, and furtherdefining a cavity 622. The needle assembly 30 is removably disposedwithin the cavity 622, wherein the needle assembly base 70 is supportedby one or more retention surfaces. The needle hub, base 70, or bothcomponents of the needle assembly 30 can be removably secured to atelescoping slide portion 624 that slides with respect to other portionsof the body 620 to enable the needle assembly to move distally when userforce is applied to the needle hub.Thus, the needle hub 62 can be pushedby a user to distally advance the distal tip of the needle 66 past thedistal end of the body 620 and into a subcutaneously implanted accessport.

The annular distal end of the insertion device body 620 is shaped toserve as a stabilization portion for stabilizing the implanted accessport when the insertion device 610 is placed over the implanted port.Securement of the base 70 and/or needle hub 62 to the slide portion 624enables the needle 66 to be slid in a distal direction, thus enablingthe slide portion 624 to serve as a guide portion for guiding the needlealong a predetermined path into the septum of the stabilized, implantedport, as desired. A slot can be provided to enable removal of theinsertion device 610 from the needle assembly 30 after insertion of theneedle 66.

FIG. 11 shows a port needle insertion device (“insertion device”) 710according to another embodiment, wherein the insertion device includes ahollow body 720 extending between proximal and distal ends, and furtherdefining a cavity 722. The needle assembly 30 is removably disposedwithin a retention feature 724, wherein the needle assembly base 70 issupported by one or more retention surfaces. As shown, the retentionfeature 724 in the present embodiment supports that base 70 such thatthe needle assembly can pivot or gimbal about a longitudinal axis of theneedle, which enables the needle 66 a limited degree of pivotingability. This ability for limited pivoting movement in turn prevents theneedle 66 from repeatedly impinging upon the same location on the septumof the implanted port, and thus causing possible leakage of the septum,when successive insertion devices 710 are used from time to time toinsert a needle into the implanted port. Note that this feature can alsobe included in other of the insertion device embodiments describedherein.

FIG. 12 depicts details of a system for inserting a needle into animplanted access port according to one embodiment, wherein an ultrasoundprobe 804 is removably received within a body 820 of a port needleinsertion device (“insertion device”) 810, as shown. The body 820further includes a reflector surface 822 that is angled to reflect anultrasound beam 828 from the probe about 90 degrees downward into theimplanted access port 80. This configuration enables the probe 804 to beused to ultrasonically image the location of the implanted access portand to pinpoint the septum 82 without the probe being placed in the wayof the needle assembly 30. An aperture 824 of the body 820 then enablesthe needle of the needle assembly 30 to pass the reflector surface 822,extend through the body 820, and enter the implanted port 80.

FIGS. 13A-13E depict an insertion device (“insertion device”) 910 forassisting with accessing a subcutaneously implanted access port or othersuitable medical device with an infusion or other needle assembly,according to one embodiment. As shown, the insertion device 910 includesa body 912 shaped to sit atop the skin of the patient and generally fitabout the access port 80 implanted under the skin. The body 912 includesa lip-like base portion 914 that makes contact with the skin surface,and as such, is smoothly shaped so as to provide patient comfort duringuse. The body 912 defines a cavity into which the implanted access port80 and the skin covering the port can be received. The body 912 thusserves as a stabilizing portion in the present embodiment forstabilizing the implanted access port 80 prior to needle insertion. Thesize of the device cavity can vary from what is shown and describedherein.

A pair of finger cutouts 916 is defined by the body 912 to enable thefingers of a user of the insertion device 910 to grasp the skin aboutthe port 80 so as to stabilize its subcutaneous position. The body 912further includes a needle guide 918 defining a hole 918A suitable forreceiving the needle of an infusion or other needle assemblytherethrough. The needle guide 918 is positioned so as to guide theneedle through the septum 84 of the implanted access port 80 when thedevice 910 is positioned as shown over the port. The needle guide 918thus serves as a guide portion in the present embodiment for guiding theneedle along a predetermined path into the septum 84 of the access port80, as desired.

Slots 920 are defined by the device body 912 to enable the device 910 tobe removed from about the subcutaneously implanted port 80 once theneedle of the needle assembly has been inserted into the port via thehole 918A of the needle guide 918. Indeed, the slots 920 enable theneedle of the needle assembly to pass therethrough, thus enabling thedevice 910 to be slipped out from under the needle assembly afterinsertion of the needle into the implanted port septum 84. The devicebody 912 further defines two cutouts 922 about the needle guide 918that, together with the finger cutouts 916, cooperate to define twoliving hinges 924. The living hinges 924 are flexible to allowdeformation of the device body sufficient to enable the device to beremoved from between the skin surface above the implanted port and theinserted needle.

In one embodiment, the guidance device 910 is used by first locating theimplanted port 80 under the skin by palpation, then placing the deviceover the implanted port 80 such that it is received within the cavitydefined by the device body 912. The user maintains both the port 80 andthe device 910 in place by placing fingers of one hand in the fingercutouts 916 so as to stabilize the port. The other hand of the user canbe used to direct the needle of an infusion needle assembly through theneedle guide 918, which guides the needle through the skin, down throughthe septum 84, and into the port reservoir. At this stage, the user canremove the device 910 from the patient by gently pulling on the devicebody opposite the slots 920 in a lateral direction. The device body 912will pull past the inserted needle by allowing the needle to passthrough the slots 920. The device body 912 will then deform (by virtueof the cutouts 922 and living hinges 924) sufficient to readily pullpast the lump of the implanted port 80 and be completely removed.

Note that the slots and cutouts can vary from what is shown anddescribed herein and can be modified according to need in otherembodiments. Also, though the insertion device 910 shown and describedherein is designed as a universal device to fit over most implantedaccess ports, the shape, size, and configuration of the insertion devicecan vary from what is disclosed herein.

The insertion devices described herein can include one or more of avariety of material including metals, metal alloys, thermoplastics(including polypropylene, polycarbonate, and acetyl resin), thermosets,naturally occurring materials, etc.

Embodiments of the invention may be embodied in other specific formswithout departing from the spirit of the present disclosure. Thedescribed embodiments are to be considered in all respects only asillustrative, not restrictive. The scope of the embodiments is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. An insertion device for accessing an access portimplanted under the skin of a patient with a needle assembly, theinsertion device comprising: a body including: a stabilizing portionthat stabilizes a position of the implanted access port when placed onthe skin of the patient atop the implanted access port, the stabilizingportion defining an open-ended cavity having an outer perimetercircumscribing a portion of the implanted access port when the insertiondevice is placed on the skin of the patient atop the implanted accessport, a portion of the needle assembly removably disposed in theopen-ended cavity; and a guide portion for guiding a needle of theneedle assembly along a predetermined path such that the needletranscutaneously pierces a septum of the implanted access port.
 2. Theinsertion device as defined in claim 1, wherein the stabilizing portionincludes a lip around a bottom perimeter thereof.
 3. The insertiondevice as defined in claim 1, wherein a plurality of finger cutouts aredefined on the stabilizing portion, and wherein the outer perimeterdefines a substantially round shape.
 4. The insertion device as definedin claim 1, wherein the guide portion includes a needle guide.
 5. Theinsertion device as defined in claim 1, wherein the guide portionincludes a retainer component that releasably attaches to a needle hubof the needle assembly, the needle extending from the needle hub, theretainer component constraining movement of the needle in a distal andproximal direction along the predetermined path.
 6. The insertion deviceas defined in claim 5, wherein the retainer component includes aprojection that is slidably disposed within a slit that enables distaland proximal movement of the retainer component, the slit including aslit adjustment zone for adjusting a longitudinal length of the slit. 7.The insertion device as defined in claim 6, wherein the retainercomponent includes first and second articulating wings, each wingincluding a tooth that engages a portion of the needle hub to maintainreleasable attachment of the retainer component with the needle hub. 8.The insertion device as defined in claim 7, wherein the guide portionfurther includes a channel in which the retainer component is slidablydisposed, the channel including a parallel proximal portion and anoutwardly tapered distal portion, wherein the first and second wings ofthe retainer component open when the retainer component is slid distallyfrom the parallel proximal portion to the outwardly tapered distalportion, the distal sliding of the retainer component coinciding withthe distal movement of the needle hub so as to enable the needle topierce the septum of the implanted access port, the opening of the firstand second wings causing the retainer component to release engagementwith the needle hub.
 9. The insertion device as defined in claim 7,wherein each of the first and second wings includes a pin, wherein theguide portion further includes first and second channels in which thepin of the respective first or second wing is slidably received, each ofthe first and second channels including a parallel proximal portion andan diverging distal portion, wherein the first and second wings of theretainer component open when the retainer component is slid distally,the opening of the first and second wings being caused by the distalmovement of the first and second pins from the parallel proximal portionto the diverging distal portion of the first and second channels, thedistal sliding of the retainer component coinciding with the distalmovement of the needle hub so as to enable the needle to pierce theseptum of the implanted access port, the opening of the first and secondwings causing the retainer component to release engagement with theneedle hub.
 10. The insertion device as defined in claim 5, wherein theneedle assembly includes a base that is slidably disposed on the needle,the base being the portion of the needle assembly removably disposed inthe open-ended cavity.
 11. The insertion device as defined in claim 10,wherein the body further includes a slot defined adjacent the open-endedcavity, the slot for enabling removal of the insertion device from theneedle assembly when the needle has been inserted into the septum of theimplanted access port.
 12. An insertion device for accessing an accessport implanted under the skin of a patient with a needle assembly, theinsertion device comprising: a body including: a stabilizing portiondefining an open-ended cavity having an outer perimeter circumscribing aportion of the implanted access port when the insertion device is placedon the skin of the patient atop the implanted access port, a portion ofthe implanted access port being received within the open-ended cavity, aportion of the needle assembly removably disposed in the open-endedcavity; and a guide portion including a retainer component movablyattached to the body and removably retaining a hub of the needleassembly, wherein the guide portion guides a needle of the needleassembly along a predetermined path through the open-ended cavity totranscutaneously pierce a septum of the implanted access port.
 13. Theinsertion device as defined in claim 12, wherein the retainer componentincludes first and second articulating wings, each of the first andsecond articulating wings including a tooth that engages a portion of aneedle hub of the needle assembly to maintain releasable attachment ofthe retainer component with the needle hub.
 14. A needle insertionsystem for accessing an access port implanted under the skin of apatient, the system comprising: a needle assembly including a base and ahub; an insertion device, the needle assembly removably attached to theinsertion device, the insertion device including: a stabilizing portionthat stabilizes a position of the implanted access port when placed onthe skin of the patient atop the implanted access port, the stabilizingportion defining an open-ended cavity having an outer perimetercircumscribing a portion of the implanted access port when the insertiondevice is placed on the skin of the patient atop the implanted accessport, the base removably disposed in the open-ended cavity; and a guideportion for guiding a needle of the needle assembly along apredetermined path such that the needle transcutaneously pierces aseptum of the implanted access port.
 15. The needle insertion system asdefined in claim 14, wherein the guide portion includes a retainercomponent that releasably attaches to the hub of the needle assembly andslides in a channel longitudinally defined on the insertion device. 16.The needle insertion system as defined in claim 15, wherein the guideportion is included with a body of the insertion device, the bodyincluding a plurality of articulating arms, a proximal end of eacharticulating arm removably attaching to a portion of the needleassembly, a distal end being attached to a portion of the body, whereincollapse of the articulating arms by user force guides the needle of theneedle assembly to pierce the septum of the implanted access port. 17.The needle insertion system as defined in claim 15, wherein the guideportion is included with a body of the insertion device, the guideportion including a slide portion slidably disposed with the body, theslide portion releasably retaining the needle assembly, the insertiondevice further including a needle cover that is removably attached to adistal end of the body so as to protect a distal tip of the needlebefore use of the insertion device.
 18. The needle insertion system asdefined in claim 17, wherein the needle assembly is retained by theslide portion such that the distal tip of the needle is able to pivotabout a longitudinal axis of the needle.
 19. The needle insertion systemas defined in claim 15, wherein the guide portion is at least partiallydefined by a body of the insertion device, the needle assembly beingslidably disposed within a cavity defined by the body, the body furtherincluding a removable lower body portion, the lower body portiondefining a lower body cavity, the lower body cavity defining thestabilizing portion.
 20. The needle insertion system as defined in claim19, wherein an antimicrobial barrier is disposed in one of the cavityand the lower body cavity of the lower body portion.
 21. An insertiondevice for accessing an access port that is subcutaneously implanted ina body of a patient, the insertion device comprising: a body defining acavity for receiving therein at least a portion of the implanted accessport and skin surface above the port, the body further defining: aneedle guide for guiding a needle for insertion into a septum of theimplanted access port; a slot for enabling removal of the insertiondevice past the needle after insertion into the septum of the implantedaccess port; and at least one cutout for permitting deformation of thebody so as enable removal of the insertion device past the needle afterinsertion into the septum of the implanted access port.
 22. Theinsertion device as defined in claim 21, wherein the body furtherincludes at least one cutout for enabling a user to grasp the skinsurface covering the implanted access port while the insertion device isin place atop the implanted access port.
 23. An insertion device foraccessing an access port implanted under the skin of a patient with aneedle assembly, the needle assembly including a needle extending from ahub, the insertion device comprising: a body including: a slit includinga slit adjustment zone for adjusting a longitudinal length of the slit;a stabilizing portion that stabilizes a position of the implanted accessport when placed on the skin of the patient atop the implanted accessport; and a guide portion for guiding the needle along a predeterminedpath such that the needle transcutaneously pierces a septum of theimplanted access port, the guide portion including a retainer componentthat releasably attaches to the hub, the retainer component including aprojection slidably disposed within the slit to enable distal andproximal movement of the retainer component, the retainer componentconstraining distal and proximal movement of the needle along thepredetermined path.
 24. An insertion device for accessing an access portimplanted under the skin of a patient with a needle assembly, the needleassembly including a needle extending from a hub and a base slidablydisposed on the needle, the base removably attached to the insertiondevice, the insertion device comprising: a body including: a stabilizingportion that stabilizes a position of the implanted access port whenplaced on the skin of the patient atop the implanted access port, thestabilizing portion including a cavity and a slot in communication withthe cavity, the slot enabling removal of the insertion device from theneedle assembly following insertion of the needle into the implantedaccess port; and a guide portion for guiding the needle along apredetermined path such that the needle transcutaneously pierces aseptum of the implanted access port, the guide portion including aretainer component that releasably attaches to the hub, the retainercomponent constraining distal and proximal movement of the needle alongthe predetermined path.